EUCTR2018-001967-22-FR招募中1 期
A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study theEfficacy and Safety of Pembrolizumab (MK-3475) in Combination with Bacillus Calmette-Guerin (BCG) in Participants with High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) that is either Persistent or Recurrent Following BCG Induction or that is Naïve to BCG Treatment (KEYNOTE-676) - A Phase 3 trial of BCG with or without pembrolizumab (MK-3475) for HR NMIBC (KEYNOTE-676)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 1,525
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Cohort A-BCG Post-induction Cohort
- •1. Male/female participants who are at least 18 years of age on the day of providing documented informed consent will be enrolled in this study
- •2. Have BICR-confirmed histological diagnosis of high-risk non-muscle invasive (T1, highgrade Ta and/or CIS) UC of the bladder
- •3. Have been treated with one adequate course of BCG induction therapy for the treatment of HR NMIBC defined as at least 5 intravesical instillations of BCG within a 10-week period of time
- •4. Following adequate BCG induction therapy, must have persistent or recurrent HR NMIBC
- •5. Have undergone cystoscopy/TURBT to remove all resectable disease within 12 weeks prior to randomization
- •6. Have provided tissue for biomarker analysis from the most recent TURBT/biopsy procedures from which tumor sample is available
- •7. Have a performance status of 0, 1 or 2 on the ECOG Performance Scale, as assessed within 14 days prior to randomization
- •8. Have adequate organ function. Specimens must be collected within 14 days prior to randomization
- •9. Male participants are eligible to participate if they agree to the following during the treatment period and for at least 7 days after the last dose of BCG:
- •Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent
- •Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause)
- •10. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:
- •a) Is not a WOCBP
- •b) Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the treatment period and for at least 7 days after the last dose of BCG or 120 days after the last dose of pembrolizumab, whichever comes last
- •11. The participant (or legally acceptable representative) provides documented informed consent/assent for the study. The participant may also provide consent/assent for FBR. However, the participant may participate in the main study without participating in FBR
- •Cohort B-BCG Naïve Cohort
- •12. Male/female participants who are at least 18 years of age on the day of providing documented informed consent will be enrolled in this study
- •13. Have BICR-confirmed histological diagnosis of high-risk non-muscle invasive (T1, highgrade Ta and/or CIS) UC of the bladder
- •14. Have undergone cystoscopy/TURBT to remove all resectable disease within 12 weeks prior to randomization
- •15. Have provided tissue for biomarker analysis from the most recent TURBT/biopsy procedures from which tumor sample is available
- •16. Have a performance status of 0, 1 or 2 on the ECOG performance Scale, as assessed within 14 days prior to randomization
- •17. Have adequate organ function. Specimens must be collected within 14 days prior to randomization
- •18. Male participants are eligible to participate if they agree to the following during the treatment period and for at least 7 days after the last dose of BCG
- •Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent
- •Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical c
排除标准
- •Cohort A-BCG Post-induction Cohort
- •1. Has persistent (remains present or occurs within 3 months (–2 weeks) to 6 months (+4 weeks) after start of BCG induction T1 disease following an induction course of BCG
- •2. Has a history of or concurrent locally advanced non-resectable (ie, T2, T3, T4) or metastatic UC
- •3. Has concurrent extra-vesical non-muscle invasive urothelial carcinoma, concurrent upper tract involvement, or invasive prostatic UC including T1 or greater disease, or ductal invasion
- •4. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
- •5. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks of start of study treatment
- •6. Has received prior radiotherapy within 2 weeks of start of study treatment
- •7. Has received a live vaccine within 30 days of start of study treatment
- •8. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks of start of study treatment
- •9. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days of start of study treatment
- •10. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- •11. Has hypersensitivity to pembrolizumab and/or any of its excipients
- •12. Has an active autoimmune disease that has required systemic treatment in past 2 years
- •13. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
- •14. Has 1 or more of the following contraindications to BCG: prior BCG sepsis or systemic infection, total bladder incontinence, or an adverse experience to a previous BCG instillation that resulted in treatment discontinuation and precludes retreating with BCG
- •15. Has an active infection requiring systemic therapy
- •16. Has a known history of HIV infection
- •17. Has a known history of Hepatitis B or known active Hepatitis C virus infection
- •18. Has current active tuberculosis
- •19. Has known psychiatric or substance abuse disorder that would interfere with cooperating with the requirements of the study
- •20. Has had an allogenic-tissue/solid organ transplant
- •21. Has any contraindication(s) to IV contrast or is otherwise unable to have CTU imaging with IV contrast performed
- •Cohort B-BCG Naïve Cohort
- •22. Has a history of or concurrent locally advanced or metastatic UC
- •23.Has concurrent extra-vesical non-muscle invasiveurothelial carcinoma or invasive prostatic UC including T1 or greater disease, or ductal invasion
- •24. Has any contraindication(s) to IV contrast or is otherwise unable to have CTU imaging with IV contrast performed
- •25. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
- •26. Has received any prior treatment with BCG for their NMIBC within the past 2 years prior to study entry
- •27. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks of start of study treatment
- •28. Has received prior radiotherapy within 2 weeks of start of study treatment
- •29. Has received a live vaccine within 30 days of start of study treatment
- •30. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 w
研究者
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